LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care

NCT04199052 | Completed Results DMC

• 2 other identifiers: 191398R34MH122014-01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators will develop and pilot test a culturally tailored, trauma-informed smartphone app, called LinkPositively, for Black WLHA affected by interpersonal violence. The goal is to determine preliminary effects of the intervention on HIV care (i.e., retention in HIV care, ART adherence) and mental health outcomes (e.g., PTSD, depression, anxiety). Through a randomized control trial (RCT), participants will be randomly assigned to either the intervention arm (n=40) or control arm (Ryan White standard of care, n=40), with follow-up at 3- and 6- months. This study will benefit the advancement of HIV prevention science by harnessing technology to promote engagement in HIV care, while improving social support through peers and social networking-all under the auspices of being trauma-informed for Black WLHA with experiences of interpersonal violence.

Conditions

HIV/AIDS

Keywords

HIV Care Continuum, Mobile Apps

Outcome Measures

Primary Outcomes (6)

• Number of HIV Care Visits

  Median number of HIV care visits

  3 Months Post-Baseline

• Number of HIV Care Visits

  Median number of HIV care visits in past 6 months

  6 Months Post-Baseline

• Number of Participants With ART Adherence

  Dichotomized into two groups (Greater than or equal to 90% adherence to ART regime (self-report) based on the Wilson 3-item adherence self-report items vs. Less than 90% adherence to ART regime (self-report) based on the Wilson 3-item adherence self-report items)

  3 Months Post-Baseline

• Number of Participants With ART Adherence

  Dichotomized into two groups (Greater than or equal to 90% adherence to ART regime (self-report) based on the Wilson 3-item adherence self-report items vs. Less than 90% adherence to ART regime (self-report) based on the Wilson 3-item adherence self-report items)

  6 Months Post-Baseline

• HIV Adherence Self-Efficacy

  HIV Adherence Self-Efficacy measured using the HIV Adherence Self-Efficacy Scale, minimum=0, maximum=10; higher scores mean greater self-efficacy to adhere to HIV medication.

  3 Months Post-Baseline

• HIV Adherence Self-Efficacy

  HIV Adherence Self-Efficacy measured using the HIV Adherence Self-Efficacy Scale, minimum=0, maximum=10; higher scores mean greater self-efficacy to adhere to HIV medication.

  6 Months Post-Baseline

Secondary Outcomes (6)

• National Stressful Events Survey PTSD Short Scale Score

  3 Months Post-Baseline

• National Stressful Events Survey PTSD Short Scale Score

  6 Months Post-Baseline

• Patient Health Questionnaire for Depression Score

  3 Months Post-Baseline

• Patient Health Questionnaire for Depression Score

  6 Months Post-Baseline

• Generalized Anxiety Disorder Score

  3 Months Post-Baseline

Study Arms (2)

Standard of Care

NO INTERVENTION

Women assigned to the control arm will receive self-directed (non-Virtual Peer Navigator (PN) supported) treatment as usual at the HIV care service provider of choice following the Ryan White standard of care (i.e., referrals to physical, dental and mental health services; case management; and ancillary services. Annual assessments (e.g., updates on insurance, housing, referrals needed, behavioral assessment \[e.g., depression, substance use\]) are conducted by a case manager. For women who have fallen out of care and re-engage care, case management begins with an interview and assessment of current needs. Goals are set to create an individual care plan related to medical care, housing, and other resources, as needed. Referrals are made to appropriate services (e.g., primary care, housing, benefits counseling, food, support services) based on the intake assessment. It is important to note that the case management approach is self-guided versus intensive virtual PN assistance.

LinkPositively Intervention

EXPERIMENTAL

Women assigned to the LinkPositively intervention arm will have access to all four components of the LinkPositively app. Women will be scheduled for a session with staff to inform them of their assigned virtual Peer Navigator (PN). Staff will train participants on how to download the app, explain the five components, using each component, and contacting their PN. Within the first week after, virtual PNs will complete a one-on-one, in-person or phone intake session with the participant, based on the participant's preference. During this intake session, the PN will conduct a participant needs assessment to connect her to HIV medical care via local health clinics and identify other areas of need, services of need, and assisted referrals (domestic violence services, mental health care, substance abuse treatment, housing and legal support, etc.). PNs will provide trauma-informed emotional and informational support, including guidance on accessing information about referred services.

Behavioral: LinkPositively

Interventions

LinkPositively BEHAVIORAL

LinkPositively is a culturally tailored, trauma-informed smartphone app for Black women living with HIV/AIDS affected by interpersonal violence. Core components of LinkPositively include: a) Virtual Peer Navigation that includes phone and text check-ins and 4 weekly one-on-one video sessions to build skills to cope with barriers and navigate care; b) Social Networking platform to receive peer support; c) Educational and Self-care database with healthy living and self-care tips; d) GPS-enabled Resource Locator for HIV care and ancillary support service agencies; and e) ART self-monitoring and reminder system.

LinkPositively Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female gender identifying
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female Gender
• Black or African-American racial/ethnic background
• Aged 18 years or older
• HIV-positive status
• Ever experienced physical, sexual, and/or psychological abuse by a current or former partner or non-partner (e.g., relative, friend, stranger)
• Owner of a smartphone with internet browsing capabilities
• English speaking

You may not qualify if:

• Male Gender
• Aged 17 or younger
• HIV-negative status

Sponsors & Collaborators

• University of California, San Diego: lead
• San Diego State University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCSD AntiViral Research Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Jamila K. Stockman, Professor
• Organization: University of California San Diego

jstockman@health.ucsd.edu

(858) 822-4652

Study Officials

• Jamila K. Stockman, PhD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Keith J. Horvath, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators were blinded to participant study group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 13, 2019
• Study Start: September 14, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)